Predictors and Intervention for Noncompliance

Not Applicable

Completed

• Conditions: Kidney Transplantation
• Interventions: Behavioral: Intensive telephone followup

• Registration Number: NCT00148174
• Lead Sponsor: University of Minnesota

Brief Summary

This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.

Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Detailed Description

Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Kidney transplant
• Discharged from hospital with functioning graft

Exclusion Criteria

• Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
• Patients with active psychosis
• Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
• Patients taking the liquid form of azathioprine or mycophenolate mofetil
• Patients who are younger than 14 yrs. old
• Patients who do not speak English
• Receiving extra-renal organ except for pancreas,either simultaneously or previously
• Patients who live and will be followed outside of the United States, except Canada
• Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
• Patients who are not responsible for taking their own medications, e.g. living in a medical care facility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phone calling	Intensive telephone followup	Phone calling to encourage improved adherence

Primary Outcome Measures

Name	Time	Method
Graft loss	prospective

Secondary Outcome Measures

Name	Time	Method
Acute rejection	prospective
Death	prospective

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States